Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth
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ClinicalTrials.gov Identifier: NCT03327103 |
Recruitment Status : Unknown
Verified October 2020 by Randy A. Jones, University of Virginia.
Recruitment status was: Recruiting
First Posted : October 31, 2017
Last Update Posted : October 28, 2020
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Condition or disease | Intervention/treatment | Phase |
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Decision Support Techniques | Behavioral: CHAMPION | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 316 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth |
Actual Study Start Date : | July 21, 2017 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
---|---|
No Intervention: Enhanced Usual Care
Receive standard care
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Experimental: Decision Intervention
Receives decision aid intervention that encompasses balance sheets, navigation, audio files, and interaction -- Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION)
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Behavioral: CHAMPION
An interactive mHealth decision aid that includes immediate and over time quality of life (QL) graphical summaries for advanced prostate cancer patients to enhance informed, shared decision making and will also be used to assess the CPNs' role in the decision-making process. |
- Decision Conflict, Decision Regret, and Prostate Cancer Symptom Scale [ Time Frame: 9 months ]demonstrate less decisional conflict/uncertainty, higher QL (HRQL-PSY domain) and less regret at the time of making an anti-cancer treatment decision
- semi-structured interview [ Time Frame: 9 months ]evaluate community patient navigator role in delivery of decision aid

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 1) stages III/ IV prostate cancer 2) life expectancy ≥6 months 3) Karnofsky Performance Status >60 4) willingness of a DPP (patient selected person who provides decisional support) to participate 5) pair ages >18 years 6) ability to understand English
Exclusion Criteria:
- severe psychiatric problems

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327103
Contact: Randy A Jones, PhD,RN,FAAN | 434.924.0125 | raj9c@virginia.edu | |
Contact: Jane Gildersleeve, MSN | 434.466.8109 | jlg2g@virginia.edu |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Jennifer Wenzel, PhD,RN,FAAN 410-502-1114 jwenzel@jhu.edu | |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Randy A Jones, PhD,RN,FAAN 434-924-0125 raj9c@virginia.edu | |
Contact: Jane Gildersleeve, MSN 434-243-3955 jlg2g@virginia.edu | |
Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States, 23219 | |
Contact: Richard Brown, PhD 804-628-3340 rbrown39@vcu.edu |
Principal Investigator: | Randy A Jones, PhD,RN,FAAN | University of Virginia |
Responsible Party: | Randy A. Jones, Associate Professor, University of Virginia |
ClinicalTrials.gov Identifier: | NCT03327103 |
Other Study ID Numbers: |
19402 |
First Posted: | October 31, 2017 Key Record Dates |
Last Update Posted: | October 28, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
decision making advanced prostate cancer decision aid |
minorities mHealth community patient navigator |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |